MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® CAPTURING ROD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	GALILEO® CAPTURING ROD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that a 5046-100 galileo® capturing rod nut and a 5033-100 galileo® capturing rod had an issue.During a troch nail case on (b)(6) 2022, the back of the lag screw capturing rod snapped off when the surgeon went to remove the nut after insertion of the lag screw.This was discovered during use with no impact to the patient.

• Brand Name: GALILEO® CAPTURING ROD
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14828542
• Report Number: 1220246-2022-05130
• Device Sequence Number: 4813110
• Product Code: HSB
• UDI-Device Identifier: 00848665039177
• UDI-Public: 00848665039177
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K202099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GALILEO® CAPTURING ROD
• Device Catalogue Number: 5033-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown